Senior Engineer

Amgen Inc. (IR); Dublin; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

Amgen Dun Laoghaire (Co. Dublin) invites a skilled external process engineer to lead parenteral drug product operations across NPI to post-NPI phases. You will support aseptic processing, formulation, filling, lyophilisation, and transportation, while partnering with CM sites across Europe.

Travel to contract manufacturing partners is expected. Strong leadership, cGMP knowledge, and problem-solving skills are essential for success in commercial DP processing and tech transfer.

Qualifications

• Knowledge of cGMPs and regulatory requirements.
• Clean driving license and ability to travel internationally.
• Strong problem-solving and communication skills.
• Experience in drug product processing, aseptic operations and tech transfer.

Responsibilities

• Serve as drug product technical expert across parenteral manufacturing stages.
• Lead cross-site teams to set agendas and identify issues.
• Provide process development expertise for commercial DP processing.
• Troubleshoot processing technologies and equipment.
• Identify opportunities for sterile operations improvements.
• Support external supplier quality with technical evaluations.
• Visit CM sites to support milestones and build relationships.
• Build relationships with CM partners and internal teams.

Skills

Problem-solving ability

Excellent oral and written comms

Effective cross-functional leadership

Education

Bachelor’s degree in Science, Engineering or Quality

Master’s degree in Science or Engineering

Associate’s degree with 10 years related experience

Job description

Career Category Scientific Job Description Reporting to the Senior Manager of External Process Engineering, this role will be based out of Amgen Dun Laoghaire, Co. Dublin as part of the global Process Development organization.

This role will require the candidate to remotely support manufacturing at various aseptic drug product contract manufacturing sites around Europe. Assignments may include support for new product introductions, lifecycle changes and ongoing commercial production.

The candidate may support a broad range of product formats (cartridges, syringes, freeze dried and liquid vials); and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities), across multiple manufacturing sites.

Some International travel will be required to visit contract manufacturing partner sites in Europe.

The successful candidate will:

• Act as a drug product technical expert, to provide leadership and solutions when troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices, for parenteral products through the new product introduction (NPI) or post-NPI phases.
• Build excellent business relationships with contract manufacturing partners, Global Operations, External Supplier Quality, and drug product process teams.
• Demonstrate the ability to lead, via cross-site teams, and in general by setting the agenda and identifying potential issues
• Provide process development expertise for commercial drug product processing in specific areas such as aseptic processing, process characterization, technology transfer, and process validation.
• Troubleshoot issues with drug product processing technologies and equipment.
• Identify and implement operational opportunities for current and new sterile operations.
• Support commercial drug product manufacturing operations and external supplier quality with technical evaluation of NC/CAPA.
• Visit contract manufacturing sites to support key production milestones and build relationships.

Basic Qualifications:

• Knowledge of cGMP’s and other worldwide regulatory requirements.
• Proven problem-solving ability.
• Excellent oral and written communications skills.
• A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master’s degree & 3 years' directly related experience OR Associate’s degree & 10 years of directly related experience.
• Full clean driving license required to facilitate travel.

Preferred Qualifications and Experience:

• Language skills such as Italian or German would be an advantage.
• Masters or PhD in Science or Engineering.
• 5+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Process Validation.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, lyophilisation, and/or inspection processes.
• Knowledge of protein biochemistry with regard to chemical and physical stability.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of quality and regulatory systems, drug product manufacturing and process validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.

Salary Range 70,408.90 EUR - 95,259.10 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen